Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085056
Company: ORTHO MCNEIL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TYLENOL W/ CODEINE ACETAMINOPHEN; CODEINE PHOSPHATE 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
TYLENOL W/ CODEINE ACETAMINOPHEN; CODEINE PHOSPHATE 325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
TYLENOL W/ CODEINE ACETAMINOPHEN; CODEINE PHOSPHATE 325MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
TYLENOL W/ CODEINE ACETAMINOPHEN; CODEINE PHOSPHATE 325MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/09/1976 ORIG-1 Approval

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